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Quality Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Senior Associate Quality Operations
Limerick
Limerick
Microbiology Manager
Dublin
Dublin
Maintenance Planner
Carlow
Carlow
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Engineering Manager
Clare
Clare
Project Engineer
Republic of Ireland
Republic of Ireland
Project Manager
Limerick
Limerick
Clean Utilities Engineer
Carlow
Carlow
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Recruitment Consultant
Wexford
Wexford
R&D Engineer
Dublin
Dublin
Quality Systems Manager
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Program Manager
Cork
Cork
Process Support Specialist
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Project Engineer
Clare
Clare
Senior Validation Engineer
Dublin
Dublin
Chemical Engineer
Tipperary
Tipperary
QC Laboratory Technician
Carlow
Carlow
Process Engineer
Cork
Cork
Senior Electronic Engineer
Dublin
Dublin
Laboratory & Quality Manager
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
Manufacturing Engineer
Galway
Galway
Project Manager
Louth
Louth
Operations Specialist
Louth
Louth
Process Engineer (Shift)
Carlow
Carlow
Process Engineer
Limerick
Limerick
Quality Technician
Carlow
Carlow
Senior R&D Manager/Director
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
Suite Team Delivery Lead
Tipperary
Tipperary
Strategic Automation Lead
Waterford
Waterford
Facilities Engineer
Carlow
Carlow
Senior Process Enginer
Dublin South
Dublin South
Sourcing Specialist
Tipperary
Tipperary
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Clare
Clare
E&I Turnover Engineer
Carlow
Carlow
Electronic Design Engineer
Galway
Galway
R&D Senior Program Manager
Galway
Galway
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
EHS Systems Specialist
Carlow
Carlow
C&Q Lead
Tipperary
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
CQV Lead
Tipperary
Tipperary
Maintenance Engineer
Cork
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Medical Device Director
Republic of Ireland
Republic of Ireland
Senior QC 24/7 Shift
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Principal R&D Engineer
Dublin
Dublin
Manufacturing Shift Lead
Donegal
Donegal
Senior Quality Engineer
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
Senior R&D Engineer
Dublin
Dublin
Validation Engineer
Cork
Cork
Product Development Engineer
Dublin
Dublin
Product Development Engineer
Galway
Galway
Graduate R&D Engineer
Galway
Galway
Product Development Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Distribution Centre Manager
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Manufacturing Engineer
Wexford
Wexford
Process Development Engineer
Galway
Galway
Validation Engineer
Limerick
Limerick
Associate Global Trade Ops
Dublin
Dublin
Senior Project Manager - Process Develop
Dublin South
Dublin South
Trainer
Dublin
Dublin
Quality Systems Enginer
Dublin
Dublin
R&D Manager
Galway
Galway
R&D Manager
Galway
Galway
Project Engineer
Limerick
Limerick
Quality Technician
Dublin
Dublin
EHS Project Lead
Cavan
Cavan
Digital Lab Records Specialist
Tipperary
Tipperary
Quality Manager - NPI
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Pharmaceutical Operator
Louth
Louth
Manufacturing Engineer
Galway
Galway
QC Chemistry Analyst
Carlow
Carlow
R&D Director
Galway
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Quality Systems Specialist
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Clean Utilities Engineer
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
R&D Program Manager
Dublin
Dublin
Maintenance Engineer
Carlow
Carlow
Quality Technician
Dublin
Dublin
Product Development Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Senior R&D Project Manager
Galway
Galway
Aseptic Process Owner Lead
Dublin
Dublin
QC Chemistry Analyst (Shift)
Carlow
Carlow
Head of R&D
Galway
Galway
Quality Systems Specialist
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Quality Validation Engineer
Limerick
Limerick
Senior Electronics Engineer
Dublin
Dublin
Engineering Business Manager
Dublin
Dublin
Principal R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Quality Specialist
Tipperary
Tipperary
Senior EHS Specialist
Louth
Louth
Principal R&D Engineer
Galway
Galway
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
R&D Director
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Senior Quality Engineer
Limerick
Limerick
EHS Systems Specialist
Dublin
Dublin
Change Control Coordinator
Carlow
Carlow
Product Development Engineer
Galway
Galway
Quality Manager
Clare
Clare
QC Bioassay Analyst (shift)
Carlow
Carlow
Maintenance CMMS Engineer
Tipperary
Tipperary
Biomedical Engineer
Dublin
Dublin
R&D Manager
Galway
Galway
Senior Operations Manager
Tipperary
Tipperary
Senior Mechanical Engineer
Dublin
Dublin
QC Analyst
Meath
Meath
Production Operator
Carlow
Carlow
Clinical Affairs Manager
Galway
Galway
R&D Manager
Galway
Galway
Automation Engineer
Cavan
Cavan
Project Engineer
Tipperary
Tipperary
Packaging Engineer
Dublin
Dublin
Quality Specialist (hybrid)
Tipperary
Tipperary
Qualified Person
Limerick
Limerick
Senior R&D Engineer
Galway
Galway
Senior Engineering Manager
Limerick
Limerick
Quality Engineer
Galway
Galway
Process Support Specialist
Carlow
Carlow
Principal Process Equipment Engineer
Dublin South
Dublin South
Director of Quality Engineering
Limerick
Limerick
Senior HVAC Engineer
Dublin
Dublin
Senior Technical Writer
Dublin
Dublin
Senior Validation Engineer
Limerick
Limerick
Project Manager - Suite Lead
Tipperary
Tipperary
R&D Director
Galway
Galway
Senior Operations Engineer
Galway
Galway
Production Operator
Carlow
Carlow
QC Bioanalytical Analyst
Dublin
Dublin
Maintenance Reliability Engineer
Tipperary
Tipperary
Senior R&D Engineer
Dublin
Dublin
Project Process Engineer
Carlow
Carlow
Facilities Engineer
Carlow
Carlow
QA Associate Specialist
Carlow
Carlow
Specialist Operations Engineer
Tipperary
Tipperary
R&D Director
Galway
Galway
Manager/ Senior Manager Drug Product Man
Republic of Ireland
Republic of Ireland
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Process Support Specialist
Carlow
Carlow
Process Engineer
Galway
Galway
Graduate Laboratory Technician
Republic of Ireland
Republic of Ireland
Engineering Shift Technician
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Biomedical Engineer
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Electrical Engineer
Cork
Cork
Senior Quality Engineer
Dublin
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Senior Associate Quality Control
Dublin South
Dublin South
Senior QC Associate
Dublin
Dublin
Manufacturing Engineer
Limerick
Limerick
Senior Electrical Engineer
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Quality Manager
Dublin
Dublin
Senior Regulatory Affairs
Galway
Galway
Engineering Projects Lead
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Design Assurance Engineer
Galway
Galway
Senior Validation Engineer
Limerick
Limerick
Senior Quality Engineer
Dublin
Dublin
Validation Engineer
Carlow
Carlow
Electrical Engineer
Limerick
Limerick
Quality Engineer
Wexford
Wexford
Embedded Software Engineer
Dublin
Dublin
Search Results for Qualified Person
Job Title. | Location | Salary | Actions |
QA Drug Substance Manufacture LeadOur client is a leading provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. They are a global contract development and manufacturing company for biopharmaceuticals; they provide their clients with a world-leading open access technology platform. They enable their clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Due to an internal promotion, they are currently seeking to fill a critical role within the QA department. The QA Drug Substanc...Location: Louth, Republic of Ireland, |
Louth | Not Disclosed | |
Qualified PersonQualified Person Our client, a global biotech,are seeking a highly motivated and detail-oriented Qualified Person to join the quality assurance team as the Lead QP onsite. The successful candidate will have previously been a named QP on a Irish licence previously. Responsibilities Ensure manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation Ensure that biotech drug product batches are test...Location: Limerick, Limerick City, |
Limerick | Not Disclosed |
Qualified Person Career Profile
Qualified Person (QP)
The QP is the person responsible for the final release of a batch of pharmaceutical product, finished products that are ready for consumption only. To do this, they must review all of the batch files, which encompass information from many of the other departments. A QP is named on a manufacturing licence and must be qualified according to Directive 2003/94/EC. This is granted by taking a specific 2 year course, or by having a Pharmacy degree plus the required experience. Salaries in this area range from €60,000 to €90,000 for an experienced QP. Many QPs also offer their services on contract, services numerous facilities simultaneously. A desireable and lucrative job for many working in the Pharmaceutical industry.Minimum of five years experience in a Quality role.
Key Responsibilities of the QP
- Before certifying a batch prior to release the Qualified Person doing so should always ensure that the following requirements have been met:
- Each batch of finished product must be certified by a Qualified person within the EC/EEA before being released for sale or supply in the EC/EEA or for export.
- The principles and guidelines of GMP as stated in Directive 2003/94/EC for medicinal products and IMP for human use, as interpreted in the EC Guide to GMP have been followed. Ensure all requirements under references have been met prior to release of a batch.
- The principal manufacturing and testing processes have been validated.
- All the necessary Quality Control checks and tests have been performed, and account taken of the manufacturing and packaging conditions including a review of batch records.
- All necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
- All necessary manufacturing, packaging and quality control documentation has been completed and endorsed by suitably authorised staff.
- To ensure that the legal requirements regarding imported products have been fully met.
- The general conditions as laid down on the Manufacturer's License orManufacturing Authorisation (IMB) are followed.
- The QP should maintain their knowledge and experience up-to-date in the light of technical and scientific progress and changes in quality management relevant to the products which they are required to certify.
- The QP must carry out audits of GMP facilities involved in the manufacturing of medicinal products used in the clinical study.
- The QP must maintain a register of all released batches.
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The QP must promote GMP through training and guidance internally.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS